Three Core Principles to Navigate an Emerging Biotech Product Launch

Is there a recipe for navigating the unique product launch challenges that Emerging Biotech organizations endure?

Yes; however, rather than a step-by-step, how-to “recipe”, this is defined by three (3) core principles.

Three (3) Core Principles to Navigate an Emerging Biotech Product Launch

1. Maintain a clear vision of launch objectives with a centralized PMO, residing with the CEO or Head of Business Strategy

While the leaders of each business unit are responsible for defining their respective parts of a product’s ‘Go-To-Market strategy’, the program management office (PMO) is responsible for coordinating the execution across the business and information technology stakeholders:

  • Clinical Operations, Quality Management and Regulatory Filings
  • Asset Market Forecasting and Positioning
  • Pricing and Contracting, Access and Reimbursement
  • Supply Chain and Distribution
  • Customer and Patient Engagement

Ownership of the PMO function varies broadly by manufacturer. Results from Highpoint’s 2017 ‘Emerging Biotech Product Launch Optimization Survey’ reveal that ownership typically resides with the head of the Commercial organization.

While this strategy is generally acceptable, optimally, the PMO should be owned by the office of the CEO or head of Business Strategy (if one exists). This recommended ownership model safeguards the objective balance of corporate resource consumption by continuously reinforcing a focus on overall Product Launch objectives (i.e., the vision). This prevents a situation where business units are permitted to compete for priority.

Findings from Highpoint’s survey also indicate that 63 percent of Emerging Organization respondents either did not establish a centralized PMO or formed the centralized function too late in the process (within 12 or even six months of anticipated Product Launch), leaving insufficient time to coordinate efforts and meet the demands of this complex milestone event.

The PMO should be a single, centralized function with regularly contributing participants from each business unit to ensure consistent definition and understanding of the vision, progress and planning updates.

2. Mind your assumptions with a Minimum Viable ProductTM (MVPTM) phased launch roadmap

At a certain point, the proverbial rubber must meet the road (or roadmap, in this case). As described earlier, a common challenge is business units competing for priority to secure corporate resources for their respective parts of the Product Launch Roadmap. This is where the principle of Minimum Viable Product can be applied to phase your Product Launch Roadmap.

Minimum Viable ProductTM (MVPTM) is a term coined by Frank Robinson around 2001 (SyncDev MVPTM); it’s a proven methodology used to maximize the return on risk which is borne by potentially over-investing in establishing technical and non-technical functional capabilities. Application of this methodology will help mitigate overstating an assumed set of capabilities to be established in time for Product Launch vs. post-launch, by discerning the extent to which IT support is required for aspects of the business strategies on your roadmap.

The Emerging Biotech organization (or their commissioned IT Partner) can begin this process by outlining the full spectrum of IT-supported capabilities applicable to the business strategy product launch roadmap. This can be achieved through employing a combination of the following tactics (based on the nature of the product, the competitive landscape and the market):

  1. Selection from a predefined blueprint of enabling technical capabilities (that a qualified IT Service partner should be able to offer);
  2. Use of a business analysis campaign (interviews and workshops) aimed at defining the relevant processes and business requirements; and
  3. Conducting market research analysis.

The initial set of IT-supported capabilities will be identified by first classifying capabilities as motivated by either Compliance or Competitive Advantage. Any capabilities categorized as Compliance-driven, for which there are no acceptable workaround alternatives, automatically fall into Phase 1 of the Roadmap.

The “V” in MVPTM (Viable) suggests that an analysis be performed on the Competitive Advantage capabilities (potentially IT-supported business requirements) to discern which must be included in Phase 1 to satisfy Product Launch objectives. (Optimally, this is done using a quantifiable, ROI-based assessment that enables potential capabilities to be ranked.) The final consideration before ratifying the Phase 1 set of capabilities is to compare the estimated cost to achieve these capabilities to the available budget and either use the analysis to justify additional funding allocation or trim the Phase 1 scope to fit into budgetary limitations.

All remaining capabilities fall into a later, MVPTM+ phase, tentatively scheduled for future release dates, based upon groupings of ranked ROI ratings and customer feedback (Business Unit leaders, IT system users and continued market research).

3. Use a partnership model vs. a service vendor model

Emerging Organizations must adopt a partnership model with fewer vendors instead of a project-by-project or, worse yet, staff-augmentation model across a larger number of business and information technology services vendors. This achieves the elusive “win-win” for Emerging Organizations and their vendor-Partners – reducing the number of relationships maintained and time invested in selling cycles, contracts and more; all of which have a ripple effect on corporate resource consumption throughout the organization.

Manufacturers can negotiate for their partners to provide fractional/cross-utilized resources and volume-based pricing, thereby reducing both weekly and overall spend. Manufacturers and partners each benefit from collaborating on more pieces of the overall roadmap, enabling broader and more consistent understanding of how to connect the dots and identify potential gaps.

Finally, partner service providers enjoy the advantage of a larger overall, committed revenue stream with a single customer.

Ready for Action

Learn more about how to optimize for your Emerging Biotech product launch –contact Mihales Karasavas.